Development of the AMPDECIDE Decision Aid to Facilitate Shared Decision Making in Patients Facing Amputation Secondary to Chronic Limb Threatening Ischemia.

INTRODUCTION: We developed a patient decision aid to enhance patient participation in amputation level decision making when there is a choice between a transmetatarsal or transtibial amputation. METHODS: In accordance with International Patient Decision Aid Standards, we developed an amputation level patient decision aid for patients who are being considered for either a transmetatarsal or transtibial amputation, incorporating qualitative literature data, quantitative literature data, qualitative provider and patient interviews, expert panel input and iterative patient feedback. RESULTS: The rapid qualitative literature review and qualitative interviews identified five domains outcome priority domains important to patients facing amputation secondary to chronic limb threatening ischemia: 1) the ability to walk, 2) healing and risk for reamputation, 3) rehabilitation program intensity, 4) ease of prosthetic use, and 5) limb length after amputation. The rapid quantitative review identified only two domains with adequate evidence comparing differences in outcomes between the two amputation levels: mobility and reamputation. Patient, surgeon, rehabilitation and decision aid expert feedback allowed us to integrate critical facets of the decision including addressing the emotional context of loss of limb, fear and anxiety as an obstacle to decision making, shaping the decision in the context of remaining life years, and how to facilitate patient knowledge of value tradeoffs. CONCLUSIONS: Amputation level choice is associated with significant outcome trade-offs. The AMPDECIDE patient decision aid can facilitate acknowledgment of patient fears, enhance knowledge of amputation level outcomes, assist patients in determining their personal outcome priorities, and facilitate shared amputation level decision making.

The Effect of Prosthetic Limb Sophistication and Amputation Level on Self-reported Mobility and Satisfaction With Mobility.

OBJECTIVE: To determine if lower limb prosthesis (LLP) sophistication is associated with patient-reported mobility and/or mobility satisfaction, and if these associations differ by amputation level. DESIGN: Cohort study that identified participants through a large national database and prospectively collected self-reported patient outcomes. SETTING: The Veterans Administration (VA) Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls. PARTICIPANTS: 347 Veterans who underwent an incident transtibial (TT) or transfemoral (TF) amputation due to diabetes and/or peripheral artery disease and received a qualifying LLP between March 1, 2018, and November 30, 2020. INTERVENTIONS: Basic, intermediate, and advanced prosthesis sophistication was measured by the accurate and reliable PROClass system. MAIN OUTCOME MEASURE: Patient-reported mobility using the advanced mobility subscale of the Locomotor Capabilities Index-5; mobility satisfaction using a 0-10-point Likert scale. RESULTS: Lower limb amputees who received intermediate or advanced prostheses were more likely to achieve advanced mobility than those who received basic prostheses, with intermediate nearing statistical significance at nearly twice the odds (adjusted odds ratio (aOR)=1.8, 95% confidence interval (CI), .98-3.3; P=.06). The association was strongest in TF amputees with over 10 times the odds (aOR=10.2, 95% CI, 1.1-96.8; P=.04). The use of an intermediate sophistication prosthesis relative to a basic prosthesis was significantly associated with mobility satisfaction (adjusted ß coefficient (aß)=.77, 95% CI, .11-1.4; P=.02). A statistically significant association was only observed in those who underwent a TT amputation (aß=.79, 95% CI, .09-1.5; P=.03). CONCLUSIONS: Prosthesis sophistication was not associated with achieving advanced mobility in TT amputees but was associated with greater mobility satisfaction. In contrast, prosthesis sophistication was associated with achieving advanced mobility in TF amputees but was not associated with an increase in mobility satisfaction.

AMPREDICT PROsthetics-Predicting Prosthesis Mobility to Aid in Prosthetic Prescription and Rehabilitation Planning.

OBJECTIVE: To develop and validate a patient-specific multivariable prediction model that uses variables readily available in the electronic medical record to predict 12-month mobility at the time of initial post-amputation prosthetic prescription. The prediction model is designed for patients who have undergone their initial transtibial (TT) or transfemoral (TF) amputation because of complications of diabetes and/or peripheral artery disease. DESIGN: Multi-methodology cohort study that identified patients retrospectively through a large Veteran's Affairs (VA) dataset then prospectively collected their patient-reported mobility. SETTING: The VA Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls. PARTICIPANTS: Three-hundred fifty-seven veterans who underwent an incident dysvascular TT or TF amputation and received a qualifying lower limb prosthesis between March 1, 2018, and November 30, 2020 (N=357). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The Amputee Single Item Mobility Measure (AMPSIMM) was divided into a 4-category outcome to predict wheelchair mobility (0-2), and household (3), basic community (4), or advanced community ambulation (5-6). RESULTS: Multinomial logistic lasso regression, a machine learning methodology designed to select variables that most contribute to prediction while controlling for overfitting, led to a final model including 23 predictors of the 4-category AMPSIMM outcome that effectively discriminates household ambulation from basic community ambulation and from advanced community ambulation-levels of key clinical importance when estimating future prosthetic demands. The overall model performance was modest as it did not discriminate wheelchair from household mobility as effectively. CONCLUSIONS: The AMPREDICT PROsthetics model can assist providers in estimating individual patients' future mobility at the time of prosthetic prescription, thereby aiding in the formulation of appropriate mobility goals, as well as facilitating the prescription of a prosthetic device that is most appropriate for anticipated functional goals.

Comparing Patient and Provider Priorities Around Amputation Level Outcomes Using Multiple Criteria Decision Analysis.

BACKGROUND: Patients with chronic limb threatening ischemia may require a transmetatarsal amputation (TMA) or a transtibial amputation. When making an amputation-level decision, these patients face a tradeoff-a TMA preserves more limb and may provide better mobility but has a lower probability of primary wound healing and may therefore result in additional same or higher level amputation surgeries with an associated negative impact on function. Understanding differences in how patients and providers prioritize these tradeoffs and other outcomes may enhance shared decision-making. OBJECTIVES: Compare patient priorities with provider perceptions of patient priorities using Multiple Criteria Decision Analysis (MCDA). METHODS: The MCDA Analytic Hierarchy Process was chosen due to its low cognitive burden and ease of implementation. We included 5 criteria (outcomes): ability to walk, healing after amputation surgery, rehabilitation program intensity, limb length, and ease of use of prosthetic/orthotic device. A national sample of dysvascular lower-limb amputees and providers were recruited from the Veterans Health Administration with the MCDA administered online to providers and telephonically to patients. RESULTS: Twenty-six dysvascular amputees and 38 providers participated. Fifty percent of patients had undergone a TMA; 50%, a transtibial amputation. When compared to providers, patients placed higher value on TMA (72% vs. 63%). Patient versus provider priorities were ability to walk (47% vs. 42%), healing (18% vs. 28%), ease of prosthesis use (17% vs. 13%), limb length (11% vs. 13%), and then rehabilitation intensity (7% vs. 6%). LIMITATIONS: Our sample may not generalize to other populations. CONCLUSIONS: Provider perceptions aligned with patient values on amputation level but varied around the importance of each outcome. IMPLICATIONS: These findings illuminate some differences between patients' values and provider perceptions of patient values, suggesting a role for shared decision-making. Embedding this MCDA framework into a future decision aid may facilitate these discussions.

Mortality Conversations Between Male Veterans and Their Providers Prior to Dysvascular Lower Extremity Amputation.

BACKGROUND: Among patients facing lower extremity amputation due to dysvascular disease, the mortality risk is very high. Given this, as well as the importance of a patient-centered approach to medical care, informing patients about their possible risk of dying may be important during preoperative shared decision-making. The goal of this investigation was to gain an understanding of patient and provider experiences discussing mortality within the context of amputation within the Veterans Health Administration. METHODS: Semistructured interviews were performed with Veterans with peripheral arterial disease and/or diabetes, vascular and podiatric surgeons, and physical medicine and rehabilitation physicians. Interviews were analyzed using team-based content analysis to identify themes related to amputation-level decisions. RESULTS: We interviewed 22 patients and 21 surgeons and physicians and identified 3 themes related to conversations around mortality: (1) both patients and providers report that mortality conversations are not common prior to amputation; (2) while most providers find value in mortality conversations, some express concerns around engaging in these discussions with patients; and (3) some patients perceive mortality conversations as unnecessary, but many are open to engaging in the conversation. CONCLUSIONS: Providers may benefit from introducing the topic with patients, including providing the context for why mortality conversations may be valuable, with the understanding that patients can always decline to participate should they not be interested or comfortable discussing this issue.

The Development and Usability of the AMPREDICT Decision Support Tool: A Mixed Methods Study.

OBJECTIVE: Amputation level decision making in patients with chronic limb threatening ischaemia is challenging. Currently, evidence relies on published average population risks rather than individual patient risks. The result is significant variation in the distribution of amputation levels across health systems, geographical regions, and time. Clinical decision support has been shown to enhance decision making, especially complex decision making. The goal of this study was to translate the previously validated AMPREDICT prediction models by developing and testing the usability of the AMPREDICT Decision Support Tool (DST), a novel, web based, clinical DST that calculates individual one year post-operative risk of death, re-amputation, and probability of achieving independent mobility by amputation level. METHODS: A mixed methods approach was used. Previously validated prediction models were translated into a web based DST with additional content and format developed by an expert panel. Tool usability was assessed using the Post-Study System Usability Questionnaire (PSSUQ; a 16 item scale with scores ranging from 1 to 7, where lower scores indicate greater usability) by 10 clinician end users from diverse specialties, sex, geography, and clinical experience. Think aloud, semi-structured, qualitative interviews evaluated the AMPREDICT DST's look and feel, user friendliness, readability, functionality, and potential implementation challenges. RESULTS: The PSSUQ overall and subscale scores were favourable, with a mean overall total score of 1.57 (standard deviation [SD] 0.69) and a range from 1.00 to 3.21. The potential clinical utility of the DST included (1) assistance in counselling patients on amputation level decisions, (2) setting outcome expectations, and (3) use as a tool in the academic environment to facilitate understanding of factors that contribute to various outcome risks. CONCLUSION: After extensive iterative development and testing, the AMPREDICT DST was found to demonstrate strong usability characteristics and clinical relevance. Further evaluation will benefit from integration into an electronic health record with assessment of its impact on physician and patient shared amputation level decision making.

A Prospective Longitudinal Study of Trajectories of Depressive Symptoms After Dysvascular Amputation.

OBJECTIVES: Characterize the course of depressive symptoms during the first year after dysvascular amputation and identify factors that predict symptom trajectories. DESIGN: Prospective cohort study of individuals undergoing lower extremity amputation (LEA), surveyed at 4 time points (perioperative period, 6 weeks, 4 months, and 12 months postamputation). Multilevel modeling was used to describe and predict trajectories. SETTING: Four Veterans Affairs medical centers, a university hospital, and a level I trauma center. PARTICIPANTS: Participants (N=141; 74% retention) were a consecutive sample, eligible if they were undergoing their first unilateral LEA secondary to dysvascular disease. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Patient Health Questionnaire-9. RESULTS: Approximately 40% of participants endorsed at least moderate depressive symptoms at perioperative baseline. Individuals with greater depressive symptoms in the perioperative period concurrently reported greater pain, poorer self-rated health, and prior mental health treatment. In the first 6 weeks after amputation there was a substantial improvement in depressive symptoms, especially among individuals with greater symptoms at baseline. Depressive symptoms were generally stable after 6 weeks. None of the covariates assessed significantly predicted trajectories of depressive symptom improvement. CONCLUSIONS: Watchful waiting may be the most appropriate course of action for many patients in the first 6 weeks after amputation. After 6 weeks, however, symptom levels tend to stabilize, suggesting that active intervention is called for if patients remain depressed at this point. Some patients may benefit from more proactive intervention, such as those with prior mental health treatment histories.

Quality of Relationships With Caregivers, Depression, and Life Satisfaction After Dysvascular Lower Extremity Amputation.

OBJECTIVE: To describe the relationship between caregiver-specific support and conflict, and psychosocial outcomes among individuals experiencing their first dysvascular lower extremity amputation (LEA). DESIGN: Cross-sectional cohort study using self-report surveys. SETTING: Department of Veterans Affairs, academic medical center, and level I trauma center. PARTICIPANTS: Individuals undergoing their first major LEA because of complications of peripheral arterial disease (PAD) or diabetes who have a caregiver and completed measures of caregiver support and conflict (N=137; 94.9% men). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The Patient Health Questionnaire-9 to assess depression and the Satisfaction With Life Scale to assess life satisfaction. RESULTS: In multiple regression analyses, controlling for global levels of perceived support, self-rated health, age, and mobility, caregiver-specific support was found to be associated with higher levels of life satisfaction and caregiver-specific conflict was found to be associated with lower levels of life satisfaction and higher levels of depressive symptoms. CONCLUSIONS: The specific relationship between individuals with limb loss and their caregivers may be an important determinant of well-being. Conflict with caregivers, which has received little attention thus far in the limb loss literature, appears to play a particularly important role. Individuals with limb loss may benefit from interventions with their caregivers that both enhance support and reduce conflict.

Communication networks of men facing a diagnosis of prostate cancer.

AIMS AND OBJECTIVES: This study seeks to identify the factors that shape the communication networks of men who face a potential diagnosis of prostate cancer, and how these factors relate to their disclosure about their changing health status. BACKGROUND: Men facing a potential diagnosis of prostate cancer are in a challenging situation; the support benefits of disclosing their changing health status to others in their communication networks is set against a backdrop of the potential stigma and uncertainty of the diagnosis. DESIGN: All men on a prostate biopsy waiting list were eligible for inclusion in an exploratory and interpretive study. METHODS: Semi-structured interviews with 40 men explored their network structures and disclosure of health information. Thematic analysis highlighted the factors which contributed to their network structures and their disclosure about their health status. RESULTS: Four network factors shaped men's perspectives about disclosing their health status: (1) tie strength, comprising both strong and weak ties; (2) knowledgeable others, with a focus on medical professionals in the family; (3) homophily, which included other individuals with a similar medical condition; and (4) geographical proximity, with a preference for face-to-face communication. CONCLUSION: Communication networks influence men's disclosure of their health status and in particular weak ties with medical knowledge have an important role. Men who use the potential for support in their networks may experience improved psychosocial outcomes. RELEVANCE TO CLINICAL PRACTICE: Using these four network factors-tie strength, knowledgeable others, homophily or geographical proximity-to forecast men's willingness to disclose helps identify men who lack potential support and so are at risk of poor psychosocial health. Those with few strong ties or knowledgeable others in their networks may be in the at-risk cohort. The support provided in communication networks complements formal medical care from nurses and other health professionals, and encouraging patients to use their communication networks improves the psychosocial health of the men themselves, their partners and their families.

Suicidal ideation among individuals with dysvascular lower extremity amputation.

OBJECTIVE: To examine the estimated prevalence and correlates of suicidal ideation (SI) among individuals 1 year after a first lower extremity amputation (LEA). DESIGN: Cohort survey. SETTING: Four medical centers. PARTICIPANTS: A referred sample of patients (N=239), primarily men, undergoing their first LEA because of complications of diabetes mellitus or peripheral arterial disease, were screened for participation between 2005 and 2008. Of these patients, 136 (57%) met study criteria and 87 (64%) enrolled; 70 (80.5%) of the enrolled patients had complete data regarding SI at 12-month follow-up. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: SI, demographic/health information, depressive symptoms, mobility, independence in activities of daily living (ADL), satisfaction with mobility and ADL, medical comorbidities, social support, self-efficacy. RESULTS: At 12 months postamputation, 11 subjects (15.71%) reported SI; of these, 3 (27.3%) screened negative for depression. Lower mobility, lower satisfaction with mobility, greater impairment in ADL, lower satisfaction with ADL, lower self-efficacy, and depressive symptoms were all correlated with the presence of SI at a univariate level; of these, only depressive symptoms remained significantly associated with SI in a multivariable model. CONCLUSIONS: SI was common among those with recent LEA. Several aspects of an amputee's clinical presentation, such as physical functioning, satisfaction with functioning, and self-efficacy, were associated with SI, although depression severity was the best risk marker. A subset of the sample endorsed SI in the absence of a positive depression screen. Brief screening for depression that includes assessment of SI is recommended.

Changes in cognitive function from presurgery to 4 months postsurgery in individuals undergoing dysvascular amputation.

OBJECTIVE: To describe cognition among individuals with new amputations at 3 time points: presurgical, 6 weeks postamputation, and 4 months postamputation. DESIGN: Prospective cohort. SETTING: Medical centers. PARTICIPANTS: Referred sample Veterans who were primarily men (N=80) experiencing their first lower extremity amputation as a result of complications of diabetes mellitus or peripheral arterial disease. Patients were screened for the absence of gross cognitive impairment using the Short Portable Mental Status Questionnaire (SPMSQ). Of those 87 individuals who were eligible, 64% enrolled; 29 were enrolled presurgically and have cognitive data for all 3 time points, and 58 were enrolled postamputation. Eighty of the 87 individuals enrolled by 6 weeks remained enrolled at 4 months. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Demographic and general health information, general mental status (SPMSQ), and 4 brief, well-established neuropsychological measures. RESULTS: Most mean neuropsychological test scores fell in the low average or average range. For most participants, overall cognitive status improved from pre- to postsurgery and then remained stable between 6 weeks and 4 months. There were significant improvements between pre- and postsurgical test scores in verbal learning and memory, and these remained unchanged between 6 weeks and 4 months. Better 4 month cognitive performance was associated with higher perceived general health. CONCLUSIONS: Overall cognitive performance is poorest presurgically. Though there is improvement between pre- and postamputation, cognition appears generally stable between 6 weeks and 4 months.

Predicting Functional Outcomes Following Dysvascular Lower Limb Amputation: An Evidence Review of Personalizing Patient Outcomes.

Most research on people undergoing lower limb amputations for dysvascular disease summarizes average patient outcome risks and average associations between patient factors and these outcomes. More recently, the importance of predicting patient-specific outcomes based on individual factors (ie, personalized rehabilitation) has become evident. This article reviews the evidence and discusses the importance of the following: (1) predicting outcomes to facilitate amputation-level and prosthesis prescription decisions and (2) how prediction models can be leveraged to develop decision support tools to facilitate provider/patient shared decision-making to ensure decisions considering each individual patient's priorities and preferences. Examples of these tools are discussed and referenced.

Racial disparities in prosthesis abandonment and mobility outcomes after lower limb amputation from a dysvascular etiology in a veteran population.

BACKGROUND: Non-Hispanic Black (NHB) individuals have higher rates of amputation and increased risk of a transfemoral amputation due to dysvascular disease than non-Hispanic White (NHW) individuals. However, it is unclear if NHB individuals have differences in prosthesis use or functional outcomes following an amputation. OBJECTIVE: To determine if there are racial disparities in prosthesis abandonment and mobility outcomes in veterans who have undergone their first major unilateral lower extremity amputation (LEA) due to diabetes and/or peripheral artery disease. DESIGN: National cohort study that identified individuals retrospectively through the Veterans Affairs (VA) Corporate Data Warehouse (CDW) from March 1, 2018, to November 30, 2020, then prospectively collected their self-reported prosthesis abandonment and mobility. Multiple logistic regression was used to control for potential confounders and identify potential effect modifiers. SETTING: The VA CDW, participant mailings and phone calls. PARTICIPANTS: Three hundred fifty-seven individuals who underwent an incident transtibial or transfemoral amputation due to diabetes and/or peripheral arterial disease. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: (1) Self-reported prosthesis abandonment. (2) Level of mobility assessed using the Locomotor Capabilities Index. RESULTS: Rurally located NHB individuals without a major depressive disorder (MDD) had increased odds of abandoning their prosthesis (adjusted odds ratios [aOR] = 5.3; 95% confidence interval [CI]: [1.3-21.1]). This disparity was nearly three times as large for rurally located NHB individuals with MDD diagnosis, compared with other races from rural areas and with MDD (aOR = 15.8; 95% CI, 2.5-97.6). NHB individuals living in an urban area were significantly less likely to achieve advanced mobility, both with MDD (aOR=0.16; 95% CI: [0.04-7.0]) and without MDD (aOR = 0.26; 95% CI: [0.09-0.73]). CONCLUSIONS: This study demonstrated that health care disparities persist for NHB veterans following a dysvascular LEA, with increased prosthesis abandonment and worse mobility outcomes.

The effect of depression on prosthesis prescription in men and women who have undergone a lower limb amputation.

PURPOSE: To determine gender disparities and potential factors that modify prosthesis prescription practices in veteran patients who have undergone their first major unilateral amputation due to diabetes or peripheral arterial disease. MATERIALS AND METHODS: A retrospective cohort study using the VA Corporate Data Warehouse to compare prosthesis prescription rates and time to prescription between men and women veterans. The primary exposure was gender. The primary outcome was a qualifying prosthesis prescription within 12 months of the incident amputation. The secondary outcome was time to prosthesis prescription. Multiple logistic and linear regression was used to control for potential confounders and identify potential effect modification. RESULTS: 2,862 individuals met study criteria, with 1690 (60%) prescribed a qualifying prosthesis. Men were more likely to receive a prosthesis prescription than women (59% versus 45%, respectively; p = 0.03). This difference was observed primarily among those with a diagnosis of major depressive disorder. In this subgroup, the odds of men receiving a prosthesis over women was over 3 times (adjusted odds ratio = 3.3; 95% Confidence Interval, 1.5, 7.4). Men had a mean shorter time to prescription compared to women (112 ± 72 versus 136 ± 79 days, respectively, p = 0.08).Depression in women negatively impacts their prosthesis prescription rates and time to prescription compared to men. This disparity may have significant impacts on future function and quality of life.Implications for RehabilitationThis study found that men more commonly received a prosthesis prescription and received it earlier than women.This disparity was most extreme among women who had been diagnosed with major depressive disorder.Providers should identify at risk patients early and consider targeted interventions to address depression during the preoperative and immediate postoperative phases.Future research should continue to work to identify gender-specific needs that exacerbate disparity.

Peripheral neuropathy prevalence and effect on mobility 12 months after prosthesis prescription among individuals with dysvascular lower extremity amputation.

OBJECTIVE: To determine the prevalence of peripheral neuropathy (PN) and its effect on mobility in patients who were prescribed a lower limb prosthesis (LLP) after an incident dysvascular transtibial (TT) or transfemoral (TF) lower extremity amputation (LEA). We also sought to determine if the effect of PN on mobility was modified by amputation level or depression. DESIGN: Participants were identified retrospectively through the Veterans Affairs (VA) Corporate Data Warehouse (CDW) from March 1, 2018, to November 30, 2020, then were contacted prospectively to obtain their self-reported mobility. Multiple logistic regression was used to control for potential confounders and identify potential effect modifiers. SETTING: The VA CDW, the National Prosthetics Patient Database, participant mailings and phone calls. PARTICIPANTS: Three hundred fifty-seven individuals who underwent a TT or TF amputation due to diabetes and/or peripheral arterial disease and were fitted with a qualifying LLP. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: The Locomotor Capabilities Index basic and advanced mobility subscale scores. RESULTS: Two-hundred thirty seven participants (66%) had a diagnosis of PN prior to prosthesis prescription. The detrimental effect of PN on achieving basic and advanced mobility was significant after adjusting for potential confounding factors (adjusted odds ratio [aOR], 0.53; 95% confidence interval [CI], 0.30-0.94; p = .03 and aOR, 0.43; 95% CI, 0.24-0.77; p = .005, respectively). The detrimental effect of PN was more pronounced in patients with depression, especially for advanced mobility (aOR, 0.36; 95% CI, 0.14-0.95; p = .04) versus no depression (aOR, 0.53; 95% CI, 0.27-1.0; p = .07). CONCLUSIONS: PN is common in patients who have undergone an LEA due to diabetes and/or vascular disease and patients with this diagnosis should be carefully evaluated. Targeted rehabilitation programs to mitigate its potential detrimental effects on mobility are important and should specifically include mental health assessment and treatment.

Perceived shared decision-making among patients undergoing lower-limb amputation and their care teams: A qualitative study.

BACKGROUND: Shared decision-making (SDM) is increasingly advocated in the care of vascular surgery patients. The goal of this investigation was to gain a greater understanding of the patient and provider experience of SDM during clinical decision-making around the need for lower-extremity amputation and amputation level related to chronic limb-threatening ischemia (CLTI) in the Veterans Health Administration. METHODS: Semistructured interviews in male Veterans with CLTI, vascular surgeons, physical medicine and rehabilitation physicians, and podiatric surgeons. Interviews were analyzed using team-based content analysis to identify themes related to amputation-level decisions. RESULTS: We interviewed 22 patients and 21 surgeons and physicians and identified 4 themes related to SDM: (1) providers recognize the importance of incorporating patient preferences into amputation-level decisions and strive to do so; (2) patients do not perceive that they are included as equal partners in decisions around amputation or amputation level; (3) providers perceive several obstacles to including patients in amputation level decisions; and (4) patients describe facilitators to their involvement in SDM. CONCLUSIONS: Despite the recognized importance SDM in amputation decision-making, patients often perceived that their opinion was not solicited. This may result from provider perception of significant challenges to SDM posed by the clinical context of amputation. Patients identified key features that might enhance SDM including presentation of clear, concise information, and the importance of communicating concern during the discussion. These findings point to gaps in the provision of patient-centric care through SDM discussions at the time of amputation.

PROClass: The Development and Validation of a Novel Prosthetic Component Sophistication Classification System.

Objective: To develop a lower limb prosthesis (LLP) sophistication classification system that categorizes prosthetic component prescriptions into "basic," "intermediate," and "advanced" and assess its content validity, reliability, and accuracy. Design: Classification development and validation study. Setting: The Veterans Affairs (VA) Corporate Data Warehouse database and National Prosthetics Patient Database were used to identify patients undergoing their first amputation at the transtibial or transfemoral level due to diabetes or peripheral artery disease and to identify the associated codes for each LLP. Participants: An expert panel of 6 nationally recognized certified prosthetists, a national expert in VA prosthetics data and coding, a physical medicine and rehabilitation physician, and an epidemiologist developed an LLP classification system (PROClass) using 30 transfemoral and transtibial lower limb amputees. Main Outcome Measures: The expert panel reviewed 20 consecutive participants meeting study criteria for the development of the PROClass system and a subsequent 30 consecutive cases for assessing the inter- and intra-rater reliability and accuracy. Results: The interrater and intrarater reliability was almost perfect with Gwet's AC1 values ranging from .82 to .96 for both expert panel members and research assistants. The accuracy of the research assistant's classifications to the "criterion standard" was excellent with Gwet's AC1 values ranging between .75 and .92. Conclusions: PROClass is a pragmatic, reliable, and accurate prosthetic classification system with strong face validity that will enable the classification of prosthetic components used for large data set research aimed at evaluating important clinical questions such as the effects of sophistication on patient outcomes.

The Development and Pilot Study of a Multiple Criteria Decision Analysis (MCDA) to Compare Patient and Provider Priorities around Amputation-Level Outcomes.

Background. Patients with chronic limb-threatening ischemia who are facing a lower-limb amputation often require a transmetatarsal amputation (TMA) or a transtibial amputation (TTA). A TMA preserves more of the patient's limb and may provide better mobility but has a lower probability of primary wound healing relative to a TTA and may result in additional amputation surgeries. Understanding the differences in how patients and providers prioritize key outcomes may enhance the amputation decisional process. Purpose. To develop and pilot test a multiple criteria decision analysis (MCDA) tool to elicit patient values around amputation-level selection and compare those with provider perceptions of patient values. Methods. We conducted literature reviews to identify and measure the performance of criteria important to patients. Because the quantitative literature was sparse, we developed a Sheffield elicitation framework exercise to elicit criteria performance from subject matter experts. We piloted our MCDA among patients and providers to understand tool acceptability and preliminarily assess differences in patient and provider priorities. Results. Five criteria of importance were identified: ability to walk, healing after amputation surgery, rehabilitation intensity, limb length, and prosthetic/orthotic device ease. Patients and providers successfully completed the MCDA and identified challenges in doing so. We propose potential solutions to these challenges. The results of the pilot test suggest differences in patient and provider outcome priorities. Limitations. The pilot test study enrolled a small sample of providers and patients. Conclusions. We successfully implemented the pilot study to patients and providers, received helpful feedback, and identified solutions to improve the tool. Implications. Once modified, our MCDA tool will be suitable for wider rollout. Highlights: Patients and providers have successfully completed our MCDA, and patients feel the MCDA may be useful in clinical practice.We encountered several methodologic challenges and identified approaches to ease participant burden.When data are sparse, using the Sheffield elicitation framework is helpful in creating a performance matrix, although patients relied largely on their amputation experiences to complete the exercise. Blinding the alternatives may help patients better understand the process.

Understanding the experience of veterans who require lower limb amputation in the veterans health administration.

PURPOSE: There is limited qualitative research on the experience of patients undergoing lower limb amputation due to chronic limb threatening ischemia (CLTI) and their participation in amputation-level decisions. This study was performed to understand patient lived experiences related to amputation and patient involvement in shared decision making. MATERIALS AND METHODS: Phenomenological interviews were conducted with Veterans 6-12 months post transtibial or transmetatarsal amputation due to CLTI. Interviews were read and summarized by two analysts who discussed the contents of each interview and relationships between interviews to identify emergent, cross-cutting elements of patient experience. RESULTS: Twelve patients were interviewed between March and August 2019. Three cross cutting elements of patient lived experience and participation in shared decision making were identified: 1) Lacking a sense of decision making; 2) Actively working towards recovery as response to a perceived loss of independence; and 3) Experiencing amputation as a Veteran. CONCLUSIONS: Patients did not report a high level of involvement in shared decision making about their amputation or amputation level. Understanding patient experiences and priorities is crucial to supporting shared decision making for Veterans with amputation due to CLTI.